BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1063419 · Received June 19, 2008

    Report

    Report Number
    1644487-2008-01429
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PT UNDERWENT GENERATOR REPLACEMENT SURGERY DUE NORMAL END OF SVC. X-RAYS AND CT TAKEN PRIOR TO SURGERY INDICATED THAT THE PT'S LEADS WERE NOT ATTACHED TO THE VAGUS NERVE. THE PT STATED SHE WAS NEVER ABLE TO PERCEIVE STIMULATION. DURING THE SURGERY, THE SURGEON NOTED THE OLD LEAD WAS ATTACHED TO THE STERNOCLEIDOMASTOID AND NOT THE VAGUS NERVE. THE PT UNDERWENT A COMPLETE REVISION. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention